Inspection of Medical Devices (2nd Ed., 2nd ed. 2024) For Regulatory Purposes Series in Biomedical Engineering Series
Coordonnateurs : Badnjević Almir, Cifrek Mario, Magjarević Ratko, Džemić Zijad
This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements.
Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve.
This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance?a concept poised to reshape the healthcare landscape.
Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system.
Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered?welcome to the future of healthcare!
1. Introduction - Badnjevic, Cifrek, Magjarevic, Dzemic
2. Regulations and Directives - Past, present, future - Memic, Badnjevic, Dzemic
3. Legal Metrology System - Past, present, future - Bosnjakovic, Badnjevic, Dzemic
4. Medical Device maintenance regimes in healthcare institutions - Daniel Clark
5. Post-market surveillance of medical devices - Tom Judd
6. Application of AI for managment maintenance and prediction of performances - Gurbeta Pokvic, Deumic, Badnjevic
Inspection and Testing of Diagnostic Devices
7.. Inspection and Testing of ECG devices - Magjarevic, Badnjevic
8. Inspection and Testing of Noninvasive Blood Pressure Measuring Devices - Lackovic
9. Inspection and Testing of Diagnostic Ultrasound Devices - Zauhar, Diklic, Jurkovic
10. Inspection and testing of EEG, EMG and ER Equipment - Cifrek, Luka JelicInspection and Testing of Therapeutic Devices
11. Inspection and Testing of Defibrillators - Ljubotina
12. Inspection and Testing of Mechnical Ventilators and Anaesthesia Machines - Karaboce
13. Inspection and Testing of Dialysis Machines - Boskovic
14. Inspection and Testing of Pediatric and Neonate Incubators - Gurbeta Pokvic, Badnjevic Cengic
15. Inspection and Testing of Infusion Pumps - Iadanza
16. Cost Effectiveness analysis of medical devices in legal metrology system - Vukovic, Badnjevic
Almir Badnjević was born in 1986 in Bosanska Krupa, Bosnia and Herzegovina. He received his PhD from the Faculty of Electrical Engineering and Computing Zagreb (FER), University of Zagreb in 2015. Since 2008, he is working in two spheres, business and academia. In the period from 2010 to 2014, he worked in the industry of medical devices, metrology, standards and big data processing.
He is one of the founders of the idea of including medical devices with the measuring function into legal metrology framework and the establishment of measurement traceability in medical measurements globally. On that idea, in 2014, he established one of the most equipped laboratories for testing and verification of medical devices in Europe, the Verlab laboratory. The main task of Verlab is to perform annual verification of safety and performances of medical devices in all healthcare institutions of Bosnia and Herzegovina in accordance with the ISO 17020 standard. Based on the experience gained in this field, as one of the editors he wrote a book “Inspection of medical devices – for regulatory purposes” which was published by Springer Nature. In the past, he was an advisor in more than 20 Ministries of Health worldwide in the field of medical devices.In 2022, Verlab company established the first private Research Institute in Bosnia and Herzegovina, named Verlab Research Institute for Biomedical Engineering, Medical Devices and Artificial Intelligence. In less than one years, this Institute established collaborations with institutions such as CERN, Fraunhofer, Helmholtz and participate in few international projects in the field of high-performance computing, artificial intelligence and medical devices. Verlab Institute is a candidate to become a global Collaborative Center of WHO.In 2023, by Council of Ministers decision, he is appointed as director of Agency for identification documents, registers and data exchange of Bosnia and Herzegovina in the mand
Presents processes, procedures, and need for integrating medical devices into the legal realm
Helps to increase the efficacy and reliability of patient diagnoses and treatment
Is new edition with much more information about maintenance and post-market surveillance
Date de parution : 11-2023
Ouvrage de 445 p.
15.5x23.5 cm
Disponible chez l'éditeur (délai d'approvisionnement : 15 jours).
Prix indicatif 126,59 €
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